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Sign in to claim this brandMedicon Co., Ltd.
US
Last updated May 31, 2026
What Medicon Co., Ltd. makes
Medicon Co., Ltd. manufactures blue-light phototherapy lamps designed for home use, as well as shoe covers and a line of cleaning products called CLEANE, including the CLEANE POP variant.
Their portfolio includes Class I and Class II devices, with some products authorised via FDA 510(k) and UDI listings. The company operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Medicon Co., Ltd. manufacture?
Medicon Co., Ltd. specializes in blue-light phototherapy lamps intended for home use, alongside non-phototherapy devices like shoe covers and a cleaning product line called CLEANE (including the CLEANE POP variant). Their portfolio spans both Class I and Class II devices, covering a range of applications from therapeutic lighting to hygiene solutions.
Where is Medicon Co., Ltd. based, and how does that affect its regulatory oversight?
Medicon Co., Ltd. is based in the United States, meaning its devices fall under FDA jurisdiction. The FDA regulates medical devices through pathways like the 510(k) premarket notification process and Unique Device Identification (UDI) listings, which Medicon’s products appear to utilize for certain authorizations.
Which regulatory registries or databases list Medicon Co., Ltd.’s devices?
Medicon Co., Ltd.’s devices are listed in FDA registries, including the 510(k) database for premarket submissions and the UDI (Unique Device Identifier) system, which tracks device identification and compliance data. These registries ensure transparency in the device’s regulatory history and authorized status.
How are Medicon Co., Ltd.’s devices classified under FDA regulations?
Medicon’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and may require special controls or performance standards to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 688209532
Catalogue (16)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Shoe Covers | K844705 | FDA 510(k) | Class I | Active |
| Cleane | CLEANE | FDA UDI | Class II | Active |
| Infrarax Device | K850852 | FDA 510(k) | Class II | Active |
| Wheelchairs | K844574 | FDA 510(k) | Class I | Active |
| Caps (o.r. Nurse, Surgical) | K844704 | FDA 510(k) | Class I | Active |
| Ventilatory Effort Monitor | K810153 | FDA 510(k) | Class II | Active |
| Gowns, Surgical | K844703 | FDA 510(k) | Class II | Active |
| Vacuum Stretcher Immobilizer | K840034 | FDA 510(k) | Class I | Active |
| Servotronic Ec100 System | K962087 | FDA 510(k) | Class I | Active |
| Model 8300 Tester | K823197 | FDA 510(k) | Class II | Active |
| Gauze Asorbable | K844702 | FDA 510(k) | U | Active |
| Medicon #8200 Ams | K812873 | FDA 510(k) | Class II | Active |
| Absorbable Gauze Products | K844573 | FDA 510(k) | U | Active |
| Titanium Mandibular Fracture System | K952168 | FDA 510(k) | Class II | Active |
| Tens Gb1001 Device | K850855 | FDA 510(k) | Class II | Active |
| Cleane / Cleane Pop | K111341 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Medicon Co., Ltd. Wonju-si Gangwon · KR FEI 3009862779